Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
47 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-07-08
Study Completion Date
2025-01-08
Brief Summary
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The purpose of this prospective study is to analyze function and phenotype of blood neutrophils in cystic fibrosis patients and the impact of Pseudomonas aeruginosa chronic infection, treatment with CFTR modulators and acute exacerbation on blood neutrophils phenotype and function.
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Detailed Description
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Conditions
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Cystic Fibrosis
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
BASIC_SCIENCE
Blinding Strategy
NONE
Study Groups
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Stable state
45 adult cystic fibrosis patients followed in the respiratory medicine department of Cochin hospital, paris, France:
* With severe cftr mutations
* With or without PA chronic infection
* Treated or not with Ivacaftor-Lumacaftor
Group Type
EXPERIMENTAL
1 blood sample
Intervention Type
OTHER
4 tubes of 7 ml per sample (a single sample)
Starting Ivacaftor-Tezacaftor-Elexacaftor
40 adult cystic fibrosis patients followed in the respiratory medicine department of Cochin hospital, paris, France:
* With at least one severe cftr mutation
* With or without PA chronic infection
* Initiating Ivacaftor-Tezacaftor-Elexacaftor
Group Type
EXPERIMENTAL
2 blood samples
Intervention Type
OTHER
4 tubes of 7 ml per sample / 2 samples : before / after antibiotic treatment
Exacerbation
15 adult cystic fibrosis patients followed in the respiratory medicine department of Cochin hospital, paris, France and hospitalized for respiratory exacerbation
Group Type
EXPERIMENTAL
2 blood samples
Intervention Type
OTHER
4 tubes of 7 ml per sample / 2 samples : before / after antibiotic treatment
Interventions
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1 blood sample
4 tubes of 7 ml per sample (a single sample)
Intervention Type
OTHER
2 blood samples
4 tubes of 7 ml per sample / 2 samples : before / after antibiotic treatment
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* Patient over the age of 18 who is not under legal protection
* Patients with CF according to the diagnostic criteria of the Cystic Fibrosis Foundation including:
* 15 patients with severe mutation but not chronically infected with PA and not treated with lumacaftor / ivacaftor
* 15 patients homozygous phe508del, chronically infected with PA and not treated with lumacaftor / ivacaftor
* 15 patients homozygous phe508del, chronically infected with PA and treated with lumacaftor / ivacaftor
* 15 hospitalized patients for respiratory exacerbation
* 40 patients initiating Ivacaftor-Tezacaftor-Elexacaftor treatment.
* No change in baseline treatment for 15 days (including antibiotic treatment).
* Patient affiliated to a social security system
* Free, informed and written consent, dated and signed by the patient and the investigator, at the latest on the day of inclusion and before any action required by the study.
* Patients with CF according to the diagnostic criteria of the Cystic Fibrosis Foundation including:
* 15 patients with severe mutation but not chronically infected with PA and not treated with lumacaftor / ivacaftor
* 15 patients homozygous phe508del, chronically infected with PA and not treated with lumacaftor / ivacaftor
* 15 patients homozygous phe508del, chronically infected with PA and treated with lumacaftor / ivacaftor
* 15 hospitalized patients for respiratory exacerbation
* 40 patients initiating Ivacaftor-Tezacaftor-Elexacaftor treatment.
* No change in baseline treatment for 15 days (including antibiotic treatment).
* Patient affiliated to a social security system
* Free, informed and written consent, dated and signed by the patient and the investigator, at the latest on the day of inclusion and before any action required by the study.
Exclusion Criteria
* Informed consent impossible to obtain
* Involvement in an interventional research protocol in the previous 3 months if exclusion directive was given in this protocol.
* Involvement in an interventional research protocol in the previous 3 months if exclusion directive was given in this protocol.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Sponsor Role
collaborator
URC-CIC Paris Descartes Necker Cochin
OTHER
Sponsor Role
collaborator
Assistance Publique - Hôpitaux de Paris
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Pierre-Régis BURGEL, MD PHD
Role: PRINCIPAL_INVESTIGATOR
APHP
Locations
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Cochin hospital, AP-HP
Paris, , France
Site Status
Countries
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France
References
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Heijerman HGM, McKone EF, Downey DG, Van Braeckel E, Rowe SM, Tullis E, Mall MA, Welter JJ, Ramsey BW, McKee CM, Marigowda G, Moskowitz SM, Waltz D, Sosnay PR, Simard C, Ahluwalia N, Xuan F, Zhang Y, Taylor-Cousar JL, McCoy KS; VX17-445-103 Trial Group. Efficacy and safety of the elexacaftor plus tezacaftor plus ivacaftor combination regimen in people with cystic fibrosis homozygous for the F508del mutation: a double-blind, randomised, phase 3 trial. Lancet. 2019 Nov 23;394(10212):1940-1948. doi: 10.1016/S0140-6736(19)32597-8. Epub 2019 Oct 31.
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BACKGROUND
Other Identifiers
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2018-A03017-48
Identifier Type: OTHER
Identifier Source: secondary_id
APHP180430
Identifier Type: -
Identifier Source: org_study_id
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